Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS) (ALS-project)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Nervous System Disease, Neurodegenerative Disease, Motor Neuron Disease, ALS, Muscle training, Muscle atrophy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Amyotrophic lateral sclerosis (ALS)
Exclusion Criteria:
- Late stage ALS
Sites / Locations
- Department of Clinical Research, Odense University Hospital, University of Southern Denmark
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Muscle strength
Arm Description
Outcomes
Primary Outcome Measures
Improved muscle strength
Measured by Power Rig, KinCom (RFD, Interpolated twich), Calf Press exercises as well as Sway analysis and functional assesments (Timed-up-go + chair rise) Immunohistochemical, genearray, ELISA and Western Blotting analysis techniques are used to gain further data/insight.
Secondary Outcome Measures
Physical, social and mental quality of life
SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).
Full Information
NCT ID
NCT01504009
First Posted
January 2, 2012
Last Updated
June 13, 2016
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01504009
Brief Title
Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)
Acronym
ALS-project
Official Title
Investigating the Effect of Muscle Training in Patients With Amyotrophic Lateral Sclerosis and Looking Into the Mechanisms Behind Development of Muscle Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of muscle strength and functional abilities during their illness. In healthy people, regular exercise is the best way to maintain or improve muscle strength, endurance and general health status and thereby maintain functioning abilities. Previously, patients with neuromuscular diseases were advised to avoid any kind of physical exercise. However, lately a number of studies have evaluated the effect of training in patients with neuromuscular diseases, and positive effects on the functional abilities have been found. Based on these findings we want to investigate the mechanisms leading to development of muscle atrophy and loss of functional abilities, and to explore the opportunities of reducing muscle wasting and thereby improve the course of the disease development through strength training.
The main objective is to investigate the effects of strength training on slowing disease progression and reduce the decline in muscle strength and function in patients with amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies of biological processes in muscle tissue in order to unveil mechanisms leading to muscle atrophy, and to examine effects of a strength training program. The goal is to be able to incorporate strength training in the treatment program of these patients in order to maintain muscle strength and function in the individual for as long as possible.
Minimum 10 patients with the disease are included in the study. Through a 12 week period the patients will participate in strength training 2-3 times per week. Muscles biopsies will be taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning of training and (iii) after 12 weeks of strength training. Patients will function as their own controls. Blood samples will be collected simultaneously in order to follow the development of the strength training. Furthermore, participants will be assessed through at number of functional tests and questionnaires evaluating their strength, balance and social/ psychological status.
Subjects are recruited through their association with Odense University Hospital. In the present study, the participants become part of a social network, while participating in organized training sessions, and thus have a possibility to make contact with other ALS patients in the same situation as themselves.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Nervous System Disease, Neurodegenerative Disease, Motor Neuron Disease, ALS, Muscle training, Muscle atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Muscle strength
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Muscle training
Other Intervention Name(s)
Strength training, Rehabilitation
Intervention Description
12 weeks of strength training 2-3 times/week
Primary Outcome Measure Information:
Title
Improved muscle strength
Description
Measured by Power Rig, KinCom (RFD, Interpolated twich), Calf Press exercises as well as Sway analysis and functional assesments (Timed-up-go + chair rise) Immunohistochemical, genearray, ELISA and Western Blotting analysis techniques are used to gain further data/insight.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical, social and mental quality of life
Description
SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).
Time Frame
24 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Amyotrophic lateral sclerosis (ALS)
Exclusion Criteria:
Late stage ALS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik D Schroeder, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Research, Odense University Hospital, University of Southern Denmark
City
Odense C
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data has been and will be published. Individual participant data may not be available.
Learn more about this trial
Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)
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